Sufentanil Hybrid Receives CHMP Nod for Post-Op Pain

Miriam E. Tucker


July 24, 2015

Sufentanil (Zalviso, Grunenthal GmbH) has received a European government endorsement for the treatment of postoperative pain.

The positive opinion, from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), is for a hybrid medicine: a drug that is similar to an authorized medicine containing the same active substance, but that differs in characteristics such as strength, indication, or pharmaceutical form.

Zalviso is a hybrid of Sufenta (Akorn), which has been authorized in the Netherlands since 1978 as an anaesthetic-analgesic. Hybrid applications include data from studies on the new product as well as for a reference product.

The active ingredient, sufentanil, is an opioid that produces analgesia via activation of μ-opioid receptors primarily within the central nervous system. The full indication of the product, which will be sold as 15-μg sublingual tablets, is: "Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients."

The most common adverse effects are nausea, vomiting, fever, and headache.


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